Page 103 - 《中国药房》2020年22期

利奈唑胺联合常规抗结核药物治疗结核性脑膜炎有效性与安全

性的Meta分析 Δ

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文 朋 ，程登贵 ，蒋其俊 ，罗 雪 ，陈 欢（1.遵义医科大学第三附属医院/遵义市第一人民医院神经外科，
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贵州 遵义 563000；2.遵义医科大学第三附属医院/遵义市第一人民医院临床药学部，贵州 遵义 563000）
中图分类号 R529.3 文献标志码 A 文章编号 1001-0408（2020）22-2781-05
DOI 10.6039/j.issn.1001-0408.2020.22.16
摘 要 目的：系统评价利奈唑胺（LZD）联合常规抗结核药治疗结核性脑膜炎（TBM）的疗效和安全性，为临床用药提供循证参
考。方法：计算机检索PubMed、Cochrane图书馆、Embase、中国知网、万方数据等，收集LZD联合常规抗结核药物（试验组）对比常
规抗结核药物（对照组）的随机对照试验（RCT），检索时限均为建库起至2020年1月。筛选文献、提取资料后，采用Cochrane 系统
评价员手册5.2 推荐的偏倚风险评估工具对纳入文献质量进行评价，采用Rev Man 5.3软件进行Meta分析，并对结果进行敏感性
分析和发表偏倚分析。结果：共纳入 9 项 RCT，共计 602 例患者。Meta 分析结果显示，试验组患者总有效率[OR＝4.05，95％CI
（2.26，7.26），P＜0.000 01]、脑脊液蛋白含量变化幅度[MD＝0.48，95％CI（0.20，0.77），P＝0.000 8]、脑脊液白细胞计数变化幅
度[MD＝44.43，95％CI（20.06，68.81），P＝0.000 4]、脑脊液糖/同步血糖变化幅度[MD＝0.09，95％CI（0.05，0.14），P＜0.000 1]均显
著高于对照组，两组患者脑脊液氯化物含量变化幅度[MD＝8.08，95％CI（－0.64，16.80），P＝0.07]和不良反应发生率[OR＝1.34，
95％CI（0.57，3.11），P＝0.50] 比较，差异均无统计学意义。以脑积液蛋白含量变化幅度、脑脊液糖/同步血糖变化幅度为指标的敏感性
分析结果显示，与剔除前比较有显著性差异；以脑脊液白细胞计数变化幅度、脑脊液氯化物含量变化幅度为指标的敏感性分析结果显
示，与剔除前比较无显著性差异。发表偏倚分析结果显示，本研究存在一定的发表偏倚。结论：LZD联合常规抗结核药治疗TBM的
疗效和安全性均较好。由于敏感性分析结果不一致，且存在发表偏倚，故所得结论尚需更多大样本、多中心研究进一步证实。
关键词 利奈唑胺；抗结核药物；结核性脑膜炎；Meta分析；疗效；安全性

Efficacy and Safety of Linezolid Combined with Routine Anti-tuberculosis Drugs for Tuberculous
Meningitis：A Meta-analysis
WEN Peng ，CHENG Denggui ，JIANG Qijun ，LUO Xue ，CHEN Huan（1. Dept. of Neurosurgery，the Third
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Affiliated Hospital of Zunyi Medical University/Zunyi Municipal First People’s Hospital，Guizhou Zunyi
563000，China；2. Dept. of Clinical Pharmacy，the Third Affiliated Hospital of Zunyi Medical University/Zunyi
Municipal First People’s Hospital，Guizhou Zunyi 563000，China）
ABSTRACT OBJECTIVE：To systematically evaluate the efficacy and safety of linezolid（LZD）combined with routine anti-
tuberculosis drugs in the treatment of tuberculous meningitis（TBM），so as to provide evidence-based reference for clinical medi-
cation. METHODS：Retireved from PubMed，Cochrane Library，Embase，CNKI and Wanfang database，randomized controlled
trials（RCT）of LZD combined with routine anti-tuberculosis drugs（trial group）versus routine anti-tuberculosis drugs（control
group）were collected from the inception to Jan. 2020. After literature screening and data extraction， the quality of the included
literature were evaluated with bias risk assessment tool recommended by Cochrane system evaluator handbook 5.2. Meta-analysis
was conducted by using Rev Man 5.3 software，and sensitivity analysis and publication bias analysis were performed. RESULTS：
Totally 9 RCTs involving 602 patients were included. Meta-analysis showed that total response rate [OR＝4.05，95％CI（2.26，7.26），
P＜0.000 01]， changes of protein content of cerebrospinal fluid [MD＝0.48，95％CI（0.20，0.77），P＝0.000 8]，changes of white
blood cells count of cerebrospinal fluid [MD＝44.43，95％CI（20.06，68.81），P＝0.000 4]，changes of cerebrospinal fluid glucose/
synchronous blood glucose [MD＝0.09，95％CI（0.05，0.14），P＜0.000 1] of trial group were significantly higher than those of control
group. There was no statistical significance in the changes of chloride content of cerebrospinal fluid [MD＝8.08，95％CI（－0.64，
16.80），P＝0.07] and the incidence of ADR [OR＝1.34，95％CI（0.57，3.11），P＝0.50] between 2 groups. The results of sensitivity
analysis showed that there were significant differences comparison with before exclusion when the change of protein content in
cerebrospinal fluid and the change of glucose/synchronous blood glucose in cerebrospinal fluid were taken as indexes，and there
was no significant difference comparison with before exclusion when the changes of white blood cell count and chloride content in
cerebrospinal fluid were taken as indexes. The results of publication bias analysis showed that there was a certain publication bias in
this study. CONCLUSIONS：LZD combined with conventional anti-tuberculosis drugs is effective and safe for TBM. Because the
inconsistent results of sensitivity analysis and publication bias exists in publication bias analysis，the conclusions need to be further
confirmed by more large sample and multi-center studies.
Δ 基金项目：贵州省卫生健康委科学技术基金项目
KEYWORDS Linezolid； Anti-tuberculosis drugs； Tuber-
＊ 主 治 医 师 ，硕 士 。 研 究 方 向 ：功 能 神 经 外 科 。 E-mail：
812526064@qq.com culous meningitis；Meta-analysis；Therapeutic efficacy；Safety

中国药房 2020年第31卷第22期 China Pharmacy 2020 Vol. 31 No. 22 ·2781 ·